Pilocarpine Hydrochloride
Pilocarpine Hydrochloride Tablets, USP
Approved
Approval ID
0bb77eb0-f518-41bc-8212-8bcd0e75510c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 12, 2015
Manufacturers
FDA
Marlex Pharmaceuticals Inc
DUNS: 782540215
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Pilocarpine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-590
Application NumberANDA077220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2015
FDA Product Classification
INGREDIENTS (9)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 7.5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
INDIGOTINDISULFONATE SODIUMInactive
Code: D3741U8K7L
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
Pilocarpine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10135-589
Application NumberANDA077220
Product Classification
M
Marketing Category
C73584
G
Generic Name
Pilocarpine Hydrochloride
Product Specifications
Route of AdministrationORAL
Effective DateMarch 25, 2015
FDA Product Classification
INGREDIENTS (7)
PILOCARPINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 0WW6D218XJ
Classification: ACTIB
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
POLYVINYL ALCOHOLInactive
Code: 532B59J990
Classification: IACT
POLYETHYLENE GLYCOLSInactive
Code: 3WJQ0SDW1A
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
TALCInactive
Code: 7SEV7J4R1U
Classification: IACT
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT